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Completed

NCT Number: NCT07737639

Evaluating Facial Skin Quality Changes Post-Lipofilling

The goal of this prospective observational study is to evaluate changes in facial skin quality and identify predictive biological markers in donor adipose tissue in healthy women undergoing autologous facial fat transfer. The main questions it aims to answer are:

How does full-face lipofilling alter clinical signs of aging, such as wrinkles, sagging, and skin texture, over a 6-month period? Which baseline biological characteristics (e.g., cellular stemness, extracellular matrix remodeling, angiogenesis) within the donor fat graft predict these clinical skin quality outcomes?

Participants will:

Undergo a standard full-face autologous fat transfer (lipofilling) procedure. Attend follow-up evaluation visits at 1.5, 3, and 6 months post-procedure. Undergo non-invasive clinical and instrumental skin assessments (e.g., standardized photography, 3D topography, echography, and cutometry).

Complete self-assessment questionnaires regarding perceived skin changes and overall satisfaction with the procedure.

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Key information

Conditions

Facial Aging

Age range

30 year and older

Sex eligibility

Female

Study type

Observational

Primary location

L'Oréal

Aulnay-sous-Bois, 93600, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patient volunteers
  • Over the age of 30
  • Who had decided to have adipose tissue injections and declared eligible to this intervention
  • Nonsmoker or less than 5 cigarettes per day
  • Informed about the study objectives and procedures, and able to understand them
  • Willing and able to fulfil the study requirements and schedule
  • Able to give their written informed consent
  • French subjects recruited must be affiliated to the French social security system.

Exclusion criteria

  • Having participated within the 30 days before inclusion or currently participating in another clinical study.
  • Females in pregnancy or nursing
  • Dermatological disorder affecting the investigational areas (like severe acne, rosacea eczema, atopy, psoriasis, seborrheic dermatitis) that may interfere with the study conduct or the study results in the opinion of the Investigator,
  • History of skin cancer or auto-immune disease,
  • History of allergy, hypersensitivity, or any serious reaction to any medicinal or cosmetic product,
  • Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator (diabetes, HIV+, hepatitis B and C…)
  • Surgical procedure to the face (face lift)
  • Cosmetic procedures: filler injection, botulinum toxin injection, laser to the face within the past 4 months
  • Actual or past use of systemic or topic drugs, that would interfere with assessment and/or investigational treatments and affect study results in the opinion of the investigator

Treatment and study plan

Primary outcomes

  1. Change in Wrinkles and Fine Lines Severity

    Time frame: Baseline up to 6 months post-procedure

    Assessed by a trained expert using dynamic scales and photonumeric atlas books. This category evaluates the severity of crow's feet (grade 0-6), underneath eye wrinkles (grade 0-5), forehead wrinkles (grade 0-5), upper lip wrinkles (grade 0-6), nasolabial folds (grade 0-5), and cheek folds (grade 0-8). For all scales, a lower grade indicates less severe wrinkles (clinical improvement).

  2. Change in Skin Pigmentation and Color Uniformity

    Time frame: Baseline up to 6 months post-procedure

    This category includes assessments of lateral and malar pigmentation (6-point scale), dark circles (grade 0-8), full face dyschromia/skin tone heterogeneity (6-point scale), and cheek erythrosis/redness (6-point scale). Lower grades indicate reduced pigmentation and more uniform skin tone (clinical improvement).

  3. Change in Skin Elasticity, Sagging, and Structural Aging Signs

    Time frame: Baseline up to 6 months post-procedure

    Assessed clinically and via standardized photographs to evaluate structural skin changes. This includes grading of sagging/lower facial ptosis (grade 0-5), eye bags (grade 0-7), clinical skin elasticity on the cheek (6-point scale), and full face elastosis (6-point scale). Lower grades indicate less sagging and elastosis (clinical improvement).

  4. Change in Skin Texture and Surface Quality

    Time frame: Baseline up to 6 months post-procedure

    This comprehensive category encompasses full face brightness (6-point scale, where higher is better), pore visibility (grade 0-7), water mobility (grade 0-10), papyraceus/papery aspect of the cheek (6-point scale), and skin surface parameters including oiliness, shininess, dryness, and roughness (4-point scales). With the exception of brightness, lower grades generally indicate smoother, improved skin texture.

Sponsors and collaborators

Lead sponsor

L'Oreal

Industry

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

A MONOCENTER, OPEN STUDY TO ASSESS THE CHANGES INDUCED BY A LIPOFILLING PROCEDURE ON FACIAL SKIN QUALITY AND AGEING SIGNS IN WOMEN

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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